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FDA 510(k)

Clarius Ejection Fraction AI

K-Number: K253593 · 2026-03-02

ApplicantClarius Mobile Health Corp.
Decision Date2026-03-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clarius Ejection Fraction AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2026-03-02 under approval number K253593. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarius Ejection Fraction AI?

Clarius Ejection Fraction AI is a medical device that received FDA 510(k) clearance on 2026-03-02. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K253593.

When was Clarius Ejection Fraction AI approved by the FDA?

Clarius Ejection Fraction AI received FDA 510(k) clearance on 2026-03-02, under approval number K253593.

What company makes Clarius Ejection Fraction AI?

Clarius Ejection Fraction AI is manufactured by Clarius Mobile Health Corp..

What is the FDA product code for Clarius Ejection Fraction AI?

The FDA product code for Clarius Ejection Fraction AI is QIH.

Related Clinical Trials

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Related PubMed Literature

PMID: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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